CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 27, 2023

Keywords

ClinConnect Summary

This is a single-center, interventional study in Rome that looks at how the openings of the heart’s coronary arteries (coronary ostia) sit relative to a new bioprosthetic valve after surgical aortic valve replacement. Researchers want to know if the height of these artery openings changes after surgery and whether the change depends on the type of bioprosthetic valve used. Participants will have a CT scan with contrast before surgery and another CT scan at least 90 days after surgery to measure these differences. The study does not involve a random comparison or a drug, and it collects imaging data rather than testing a medication or device.

People who may be eligible are adults aged 18 to 80 with aortic valve disease that requires elective replacement with a bioprosthetic valve (and who may also have coronary disease needing treatment). Key inclusions are a planned bioprosthetic valve replacement and a pre-surgery CT scan; you must provide informed consent. Exclusions include bicuspid valves, endocarditis, other valve surgeries at the same time, prior cardiac surgery, pregnancy, allergy to iodinated contrast, and severe kidney disease. If eligible and enrolled, you’ll undergo two CT scans (before and after surgery) to help doctors understand how valve type and anatomy affect coronary artery height. The trial is currently enrolling by invitation, with results not yet available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years;
• • Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
• • Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
• • CT imaging of the thorax with iodinated contrast agent carried out before surgery;
• • Signed informed consent, inclusive of release of medical information.
• Exclusion Criteria:
• • Aortic valve replacement in bicuspid valve or endocarditis;
• • Aortic valve replacement associated with surgery of ascending aorta/aortic root;
• • Aortic valve replacement associated with other cardiac valve surgery;
• • Previous cardiac surgery of any kind;
• • Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
• • Participation in another clinical trial that could interfere with the endpoints of this study;
• • Pregnant at time of screening;
• • Allergy or hypersensitivity to iodinated contrast agent;
• • End-stage renal disease on dialysis.